FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
127897–127920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1990
STOPCOCK
K896562 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d
Cleared Feb 06, 1990
TUBING CONNECTORS
K896563 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d
Cleared Feb 06, 1990
OLYMPIC LIGHT-WARM
K896611 · KZF
Olympic Medical Corp.
General Hospital · 77d
Cleared Feb 06, 1990
WEBER PERMALOCK
K896669 · LZO
Allo Pro Corp.
Orthopedic · 71d
Cleared Feb 06, 1990
MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS
K896856 · HSX
Osteonics Corp.
Orthopedic · 63d
Cleared Feb 06, 1990
ARTEC RESPOND PULMONARY RESUSCITATOR
K896886 · BTM
Artec Environmental Monitoring Division
Anesthesiology · 60d
Cleared Feb 06, 1990
LAPAROSCOPIC ACCESS SHEATH SET
K897064 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 48d
Cleared Feb 06, 1990
R-100-ET MANUAL COLLIMATOR
K900007 · IZX
Advantech
Radiology · 35d
Cleared Feb 05, 1990
TMI LW-100 PULSED DOPPLER SYSTEM
K893861 · IYN
Titronics Medical Instruments, Inc.
Radiology · 256d
Cleared Feb 05, 1990
CIRCAMED HOLTER VERSION 4
K894956 · DPS
Circadian, Inc.
Cardiovascular · 185d
Cleared Feb 05, 1990
SUPPLEMENT TO ANAEROBIC MIC PANEL
K896332 · JWY
Microtech Medical Systems, Inc.
Microbiology · 95d
Cleared Feb 05, 1990
PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI
K896430 · DSP
Datascope Corp.
Cardiovascular · 89d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420
K896971 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
K896972 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320
K896973 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
K896974 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
K896975 · DWC
Daily Medical Products, Inc.
Cardiovascular · 54d
Cleared Feb 05, 1990
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
K897067 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 46d
Cleared Feb 05, 1990
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
K897136 · GGP
Helena Laboratories
Hematology · 40d
Cleared Feb 05, 1990
U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL
K900062 · IZO
U.S. Imaging, Inc.
Radiology · 33d
Cleared Feb 05, 1990
CRONEX QUANTA SR300 INTENSIFYING SCREEN
K900103 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 27d
Cleared Feb 05, 1990
TT AND HNTT BY HEMOCHRON
K900126 · GJA
International Technidyne Corp.
Hematology · 27d
Cleared Feb 05, 1990
CRONEX QUANTA SUPER RAPID SR339 RARE EARTH
K900318 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 13d
Cleared Feb 05, 1990
CEFIXIME 5 MCG SUSCEPTIBILITY DISK
K900344 · JTN
Organon Teknika Corp.
Microbiology · 13d